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9th July 2024  Content supplied by: INTERSCIENCE

Eugia US Manuf. LLC Testimonial - A USA Pharma's Experience of Using ScanStation for Real-time EM

Eugia US Manufacturing LLC is a subsidiary of Aurobindo Pharma. It is a US-based independent pharmaceutical company focused on generic sterile injectables, hormones, oncology, and ophthalmic medicines to cover the global market.

Works with: Scan 100 / ScanStation 300, real-time incubator and colony counter

Here, Mr. Nilkantha Banerjee, Head of Microbiology, and his team offer a ScanStation testimonial exploring the benefits of integrating ScanStation in the pharmaceutical industry.

Q: How does automating microbiological analyses with ScanStation improve your laboratory 21 CFR compliance?
Nilkantha Banerjee: Based on my review of the past 11 years data of the FDA Inspection Observations, the top 5 FDA 483 given for CFR violations in Microbiology were:

  • 21 CFR 211,160(b)Scientifically sound laboratory controls
  • 21 CFR 211, 113(b)Control of Microbiological Contamination
  • 21 CFR 211,110(a)Control Procedures to monitor and validate performance
  • 21 CFR 211,165(a)Testing and release for distribution
  • 21 CFR 211, 63 Equipment Design, Size and Location

The highest number of observations was given for 21 CFR 211.160 (b), scientifically sound laboratory controls. ScanStation 300 can mitigate these observations with early detection. The plates are read every hour, giving real-time colony counts with pictures. This robotic incubator will ensure that data integrity is followed with its 21 CFR Part 11 compliant software and also ensures there is no data falsification.

Data assurance is achieved through the review and approval process. ScanStation 300 greatly improves laboratory 21 CFR compliance and control. I believe ScanStation is revolutionary for the pharmaceutical industry.

Q: Why use ScanStation? How did you hear about the ScanStation? And why did you feel the need for automation?
Nilkantha Banerjee: I discovered ScanStation in 2015 through my personal research when trying to find equipment that can automate processes in pharmaceutical microbiology. I heard that this equipment was being used in the food industry, but I wanted it to be incorporated into the pharmaceutical industry. I introduced ScanStation to the US pharmaceutical industry in 2019.

I believe automation is needed to mitigate violations with 21 CFR 211 by allowing real-time analysis of plates during the incubation process.

Q: How does the ScanStation change your workflow?
Nilkantha Banerjee: ScanStation is very useful for understanding when the first colony appeared and on which location of the plate; this is important, especially for a plate with fungal growth.

Nilkantha Banerjee and his team: ScanStation complies with CFR by providing real-time data. It increases data traceability and reliability. Early detection of the presence of organisms in critical areas allows for early remedial actions for products, preventing monetary loss and saving brand value.

We are monitoring all our ISO 5/ Class 100/Grade A EM plates in the ScanStation. The acceptance criteria is less than 1 CFU. If a colony appears, we can notify the required personnel and start an investigation to find the root cause. If microbial growth begins on these plates before our sterility results are obtained, it is crucial to halt the subsequent levels of manufacturing and product distribution. This applies to products that were manufactured before, during and after this EM monitoring occurred. This is essential for operational safety and compliance with regulations and the data obtained adheres to 21 CFR Part 11 compliance, ensuring an Audit Trail and preventing any possibility of data falsification.

The feature that I like the most is that the ScanStation is a real-time incubator and colony counter and it allows us to take corrective actions in a timely manner if needed.
It gives us the “back in time video”, which we can check during the incubation or even after.
ScanStation hardware and software are very user-friendly.

Q: How was ScanStation introduced into your workflow?
Nilkantha Banerjee and his team: We validated the ScanStation as per our internal validation program. We did not have to change our usual protocol and we use the same media for all our incubators.

ScanStation is used daily for ISO 5 / Class 100 / Grade A Environment Monitoring. We use the “Result & Approval” module which allows a dual validation by two different Microbiologists. It brings to us data accuracy because we check the plates manually and compare with the ScanStation count during the review and approval process. If the release of plates falls on a weekend or holiday, the review and approval happen on the next working day. However, the colony counts and images automatically stop after the incubation period ends.

Full testimonial available here or use the Request Information button below to connect directly with INTERSCIENCE.

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Date Published: 9th July 2024

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